FDA UDI
In Commercial Distribution
🇺🇸 United States
Axonics
DI: 10810005340479
·
Model: 5101
·
AXONICS MODULATION TECHNOLOGIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axonics
- Primary DI
- 10810005340479
- Version / Model
- 5101
- Catalog Number
- 5101
- Company Name
- AXONICS MODULATION TECHNOLOGIES, INC.
- Labeler DUNS
- 079562449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-08
- Public Version
- 1
- Public Version Date
- 2023-09-18
- Public Version Status
- New
- Public Device Record Key
- 7c78c7e0-b485-48c9-abd7-e46e4e3bc6e1
Device Description
Neurostimulator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61391 | Implantable incontinence-control electrical stimulation system pulse generator | A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810005340479 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180046 | 056 |
| P190006 | 056 |